Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03863574 · ClinicalTrials.gov registry record · Phase 2
Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis
A Phase 2 study of Non-alcoholic Steatohepatitis, sponsored by Zydus Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 6
- Study locations
NCT03863574 is a Phase 2 study of Non-alcoholic Steatohepatitis that has completed, run by Zydus Therapeutics. The registered enrollment target is 16 participants, below the 295-participant average among 12 other Non-alcoholic Steatohepatitis trials with a reported enrollment target (95% lower). The trial reports 6 study locations across 4 states.
The verdict
NCT03863574, a Phase 2 study of Non-alcoholic Steatohepatitis, has completed, sponsored by Zydus Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a randomized, double-blind, placebo-controlled study to evaluate safety and efficacy of Saroglitazar Magnesium 2 mg and 4 mg in patients with NASH. This study will be initiated after obtaining the approvals of Institutional Ethics Committee/Institutional Review Board (IEC/IRB) and the local regulatory authority.
Conditions Studied
Interventions
- DRUG Placebos
- DRUG Saroglitazar Magnesium 2mg
- DRUG Saroglitazar Magnesium 4mg
Study Locations (6)
Tennessee
- Gastro One - Germantown
- Digestive Health Research - Hermitage
Texas
- Texas Liver Institute - San Antonio
- Clinical Trials of Texas, Inc. - San Antonio
Mississippi
- Southern Therapy and Advanced Research (STAR) LLC - Jackson
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-06-12 |
| Est. Completion | 2020-03-20 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03863574
The ClinicalTrials.gov registry entry for NCT03863574 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 295-participant average among 12 other Non-alcoholic Steatohepatitis trials with a reported enrollment target (95% lower). The listed sponsor is Zydus Therapeutics, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-alcoholic Steatohepatitis appearing as the primary indexed condition, and to 3 interventions - of which Placebos is the first listed.
NCT03863574 reports 6 study locations spanning 4 distinct geographic areas - top geographies include Tennessee, Texas, Mississippi.
Frequently Asked Questions
What is clinical trial NCT03863574 about?
NCT03863574 is a clinical study titled "Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis". This is a randomized, double-blind, placebo-controlled study to evaluate safety and efficacy of Saroglitazar Magnesium 2 mg and 4 mg in patients with NASH. This study will be initiated after obtaining the approvals of Institutional Ethics Committee/Institutional Review Board (IEC/IRB) and the local ...
What is the current status of trial NCT03863574?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2019-06-12. Estimated completion is 2020-03-20.
What conditions does trial NCT03863574 study?
This clinical trial studies the following conditions: Non-alcoholic Steatohepatitis.
What interventions are being tested in trial NCT03863574?
The interventions under investigation include: Placebos (DRUG), Saroglitazar Magnesium 2mg (DRUG), Saroglitazar Magnesium 4mg (DRUG).
Who is sponsoring clinical trial NCT03863574?
This trial is sponsored by Zydus Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03863574 being conducted?
This trial has 6 study locations across Mississippi, Tennessee, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-alcoholic Steatohepatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
RECRUITING · Phase 2
-
Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis
COMPLETED · Phase 2
-
An Evaluation of the Safety and Efficacy of Nitazoxanide on Collagen Turnover in NASH Patients With Fibrosis
COMPLETED · Phase 2
-
A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH
COMPLETED · Phase 2
-
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis
COMPLETED · Phase 2
-
Ezetimibe Versus Placebo in the Treatment of Non-alcoholic Steatohepatitis
COMPLETED · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.